Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Versus General Anesthesia

Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Anaesthetic Versus General Anaesthesia

Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract; General Anesthetic Drug Adverse Reaction; Topical Anaesthesia
• Intervention / Treatment: Drug: General Anaesthesia group; Drug: Topical Anaesthesia group

Detailed Description

This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases.

The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease.

This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery.

The following measurements will be recorded

1. Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery.
2. Need for analgesic intake after surgery will be assessed for the first 48 hours
3. Complications after surgery as irritation, infection ,and foreign body sensation were assessed
4. Patient satisfaction will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients with unilateral cataract planned for surgery under topical or general anesthesia

Exclusion Criteria:

• patients under 20 or over 70 years old Eye infection Patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group under general anesthesia for cataract surgery; Patients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics	Drug: General Anaesthesia group; General Anaesthesia will be given to this group undergoing cataract surgery
Active Comparator: Group under topical anaesthesia; Patients will receive topical anaesthesia for cataract surgery	Drug: Topical Anaesthesia group; This group of patients will only receive topical anaesthesia for Cataract surgery; Other Names: Topical group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).	At 24 hours, one week and 6 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).	Complications including hypotension, nausea and allergic reaction will be assessed after surgery and 24 hours later. satisfaction assessment will evaluate patient safety, pain control, comfort, nausea, interaction with the surgical team, willingness to repeat the anaesthetic, and relaxation during and after surgery. Patient satisfaction will be recorded at one week and six weeks postoperatively.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Radwa S Raslan, PHD, AMUH

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: 0307211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No